(158 days)
The P-ARTIS CT scanner is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system is intended for scanning patients while seated.
The P-ARTIS CT scanner is an adaptation of the cleared Philips AcQSim-Multislice-CT scanner (K033357, aka Brilliance Big Bore 16 Slice CT scanner) for imaging patients in a seated position. This adaptation is designed by P-Cure in agreement with Philips Medical Systems (Cleveland), Inc. P-Cure has developed a patient Chair and a wall mounted Sliding Platform that is responsible for moving the Gantry up and down along the center axis of the Gantry opening while the patient is seated. The Gantry motion serves to position the scan plane at the start of the region to be scanned and to increment the position of the scan plane during the scan itself.
Being a modification of the cleared Philips AcQSim CT scanner, the principal mode of operation and the essential principles of operation are the same as those of the AcQSim CT scanner. A difference yet exists in the implementation of the scan plane incrementation: instead of moving the table with the lying patient In and Out of the scan plane, the P-ARTIS moves the Gantry scan plane Up and Down over the seated patient. The relative motion is however considered identical between the two systems.
The provided text describes the P-ARTIS CT scanner, a modified version of an existing CT system (Philips AcQSim-Multislice-CT scanner), adapted for scanning patients in a seated position. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than detailed performance criteria or a standalone clinical study for a novel AI/device.
Therefore, much of the requested information regarding acceptance criteria, study design for AI/human-in-the-loop performance, and detailed ground truth establishment is not explicitly available in this document. The document describes a device modification rather than a new AI or diagnostic algorithm, and as such, the testing described is primarily focused on safety, performance comparability to the predicate, and functionality of the physical system.
However, based on the provided text, I can extract the following information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of quantitative acceptance criteria with corresponding device performance metrics for diagnostic accuracy (e.g., sensitivity, specificity). Instead, it states:
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety and Performance Compliance | "Tests results indicated that the P-ARTIS CT scanner performs according to its specifications and to the requirements established for a CT scanner." |
| Electrical Safety | Passed tests according to AAMI/ANSI ES60601-1. |
| Electromagnetic Compatibility (EMC) | Passed tests according to IEC 60601-1-2 standards. |
| Imaging Capabilities & Accuracy (Bench Testing) | "Bench testing, performed using phantoms and demonstrated the imaging capabilities and accuracy of the P-ARTIS CT scanner and its comparability to the Philips AcQSim predicate." |
| Software Verification & Validation | Verified and validated. |
| Substantial Equivalence | The P-ARTIS CT scanner is "as safe and effective as its predicate devices for its intended use and is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "Bench testing, performed using phantoms." This implies physical phantoms were used for testing, not patient data in the traditional sense of a clinical trial.
- No specific sample size for a "test set" of patient data is mentioned, nor is there information about data provenance (country of origin, retrospective/prospective). This is consistent with a 510(k) for a device modification without a new clinical indication requiring patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. Ground truth in this context would relate to the physical properties measured by phantoms during bench testing, not expert interpretation of clinical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided, as this was not a study evaluating human interpretation or diagnostic accuracy on clinical cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was described. The device is a CT scanner, not an AI-assisted diagnostic tool as understood in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device being reviewed is a CT scanner system, not a standalone algorithm in the typical sense of AI or image processing software. Its performance verification involved bench testing with phantoms and demonstration of comparability to its predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "Bench testing," the ground truth was based on the known physical properties and measurements from phantoms.
8. The sample size for the training set
- Not applicable/Not provided. This is a modified CT scanner, not an AI model requiring a training set of data.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.